International Medical Devices Database

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

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Type of Event
Safety alert / Field Safety Notice
Date
2017-04-21
Event Date Posted
2017-04-21
Event Country
United Kingdom
Event Source
MHRA
Event Source URL
https://www.gov.uk//drug-device-alerts/lma-mad-nasal-intranasal-mucosal-atomization-device-might-not-deliver-a-fully-atomised-plume-of-medication
Notes / Alerts

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Manufactured by teleflex – failure of the device to deliver an atomised plume may impair the effectiveness of the medication, potentially resulting in serious injury or a life-threatening situation.
Action
Identify and quarantine affected devices (details below) Contact Teleflex to acknowledge receipt of their field safety notice (FSN), dated 28 October 2016, even if you don’t have affected devices left in stock Return all affected devices to Teleflex.

Device

LMA® MAD Nasal™ intranasal mucosal atomization device

Model / Serial
Manufacturer
Teleflex

Manufacturer

Teleflex

Manufacturer Address
Teleflex Customer Service Maquet Ltd Tel: 01494 532 761Email orders.uk@teleflex.com
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
MHRA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Safety Alert Or Field Safety Notices for LMA® MAD Nasal™ intranasal mucosal atomization device

What is this?

Device

LMA® MAD Nasal™ intranasal mucosal atomization device

Manufacturer

Teleflex